Tranzyme Pharma Announces Top-Line Results of TZP-102 Phase 2b Trial

RESEARCH TRIANGLE PARK, N.C., Nov. 15, 2012 (GLOBE NEWSWIRE) --
Tranzyme Pharma (Nasdaq:TZYM), today announced top-line results of
the preliminary analysis of the first of two Phase 2b trials
assessing the safety and efficacy of its oral ghrelin agonist,
TZP-102 in diabetic patients with gastroparesis. The results, which
evaluated patients who were given a single daily dose of 10 mg of
TZP-102, 20 mg of TZP-102 or placebo for 12 weeks indicate the
trial did not meet its primary efficacy endpoint.

"We are understandably disappointed with the results of this
trial; however, our second Phase 2b trial known as DIGEST is
ongoing. In DIGEST we are evaluating a 10 mg dose of TZP-102
administered three times daily before meals, rather than once daily
as in the trial just completed. We anticipate announcing top line
results for DIGEST in the first half of 2013," said Vipin K. Garg,
PhD, President and Chief Executive Officer of Tranzyme.

The primary efficacy endpoint of the trial was the change from
baseline in the Gastroparesis Symptom Daily Diary (GSDD) composite
score during the final two weeks of a 12-week treatment period. The
GSDD composite score reflects the mean severity of the four
principal symptoms of
gastroparesis: nausea, early satiety, bloating and upper abdominal
pain. During the two-week pre-treatment period, the mean baseline
GSDD score across all treatment groups was 3.56. Patients who
received either placebo or once-daily dosing of TZP-102 for 12
weeks demonstrated a reduction in the severity of their symptoms,
and thus a reduction in their GSDD scores of -1.46, -1.70 and -1.43
for placebo,
10 mg of TZP-102 and 20 mg of TZP-102, respectively. Neither the 10
mg dose group nor the 20 mg dose group of TZP-102 reached
statistical significance versus placebo. Both doses were
well-tolerated.

Conference Call Details

Tranzyme will host a conference call today at 8:00 am ET. To
participate in the live call, please dial (877) 670-9784 (U.S.
and
Canada) or (970) 315-0430 (international), five to ten minutes
prior to the start of the call. A live audio webcast will also be
available in the "Investors" section of the Tranzyme Pharma
website, www.tranzyme.com.

A replay of the conference call will be available from today at
11:00 am ET through November 21, 2012. Investors may listen to the
replay by dialing (855) 859-2056 (U.S. and Canada) or (404)
537-3406 (international), with the conference id 68345812. The
webcast will also be archived for on-demand listening for 30 days
at www.tranzyme.com.

TZP-102 Phase 2b Study Design

Two hundred and one (201) patients with type 1 or type 2
diabetes and a confirmed diagnosis of gastroparesis, documented by
the presence of both chronic symptoms and delayed gastric emptying,
were enrolled in a Phase 2b, double-blind, placebo-controlled,
parallel group study in the U.S. and Europe designed to evaluate
the safety and efficacy of TZP-102. Patients were randomly assigned
to receive placebo or one of two dose levels of TZP-102 (10 or 20
mg) given once daily for a treatment period of 12 weeks.

About TZP-102

TZP-102 is an orally-administered ghrelin agonist with
highly-differentiated "first-in-class" potential for the treatment
of chronic gastrointestinal dysmotility disorders such as
gastroparesis, functional dyspepsia and refractory GERD. Ghrelin is
a hormone produced mainly by cells of the stomach which has a
highly potent and direct role in stimulating GI motility. TZP-102,
discovered by Tranzyme using its proprietary macrocyclic chemistry
technology (MATCH(TM)), targets the same receptor as the ghrelin
hormone. Tranzyme is currently evaluating the safety and efficacy
of TZP-102 in diabetic patients with gastroparesis. Gastroparesis
is a debilitating, chronic condition that has a significant impact
on patients' lives and for which there are limited treatment
options. In recognition of the critical unmet need, the FDA granted
TZP-102 a Fast Track designation for the treatment of gastroparesis
in diabetic patients.

About Gastroparesis

Gastroparesis (paralysis of the stomach) is a serious,
debilitating condition that affects approximately 4% of the general
population and up to 12% of patients with diabetes. It is a
progressive disorder characterized by persistent nausea, vomiting,
dehydration and difficulty digesting. Gastroparesis results in
complications with diabetic medicine, making it difficult for
patients to control nutritional and blood glucose levels.
Currently, there are no safe and effective treatments for
gastroparesis. Earlier prescription medications for this indication
were withdrawn from the market or must carry a "black box" warning
due to serious side effects.

About Tranzyme Pharma

Tranzyme Pharma is a clinical-stage biopharmaceutical company
focused on discovering, developing and commercializing novel,
mechanism-based therapeutics for the treatment of upper
gastrointestinal (GI) motility disorders. While approximately 40%
of people in the U.S. are affected by these persistent and
recurring conditions, which disrupt the normal movement of food
throughout the GI tract, there are a limited number of safe and
effective treatment options. Tranzyme is developing TZP-102, an
oral ghrelin agonist for treating the symptoms associated with
chronic upper GI motility disorders. Enrollment is ongoing in
DIGEST, a second Phase 2b trial evaluating TZP-102 given prior to
meals in diabetic patients with gastroparesis. Top-line data for
this study are expected in the first half of 2013. By leveraging
its proprietary drug discovery technology, MATCH(TM), Tranzyme is
committed to pursuing first-in-class medicines to address areas of
significant unmet medical needs.

Further information about Tranzyme Pharma can be found on the
Company's web site at www.tranzyme.com.

Forward-Looking Statements

Statements in this press release may include statements which
are not historical facts and are considered forward-looking within
the meaning of Section 27A of the Securities Act and Section 21E of
the Securities Exchange Act, which are usually identified by the
use of words such as "anticipates," "believes," "estimates,"
"expects," "intends," "may,"
"plans," "projects," "seeks," "should," "will," and variations of
such words or similar expressions. We intend these forward-looking
statements to be covered by the safe harbor provisions for
forward-looking statements contained in Section 27A of the
Securities Act and Section 21E of the Securities Exchange Act and
are making this statement for purposes of complying with those safe
harbor provisions.
These forward-looking statements reflect our current views about
our plans, intentions, expectations, strategies and prospects,
including the timing of the availability of data from our clinical
trial of TZP-102, which are based on the information currently
available to us and on assumptions we have made. Although we
believe that our plans, intentions, expectations, strategies and
prospects as reflected in or suggested by those forward-looking
statements are reasonable, we can give no assurance that the plans,
intentions, expectations or strategies will be attained or
achieved. Furthermore, actual results may differ materially from
those described in the forward-looking statements and will be
affected by a variety of risks and factors that are beyond our
control including, without limitation, risks related to enrollment
and successful completion of our trials, risk of unforeseen side
effects, risks related to our collaborations and risks related to
regulatory approval of new drug candidates. Further information on
these and other factors that could affect the company's financial
results is contained in our public filings with the Securities and
Exchange Commission (SEC) from time to time, including our Form
10-Q for the quarter ended September 30, 2012 which was filed with
the SEC on November 9, 2012, and subsequent filings with the SEC.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. We assume no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.